Trusted CMC Advisors

Sean Forestell, PhD
Senior Vice President

Sean Forestell, Ph.D. is an expert in biologics process development and manufacturing with over 30 years of experience in the biotech industry. Dr. Forestell has had senior leadership roles in several companies including BioMarin, Genentech and Novartis. At BioMarin, he was the Senior Director of MSAT responsible for technical process support of 5 commercial and 4 clinical products across 4 manufacturing facilities. He has developed processes and been involved in the successful tech transfer of 12 early-stage clinical products, 4 successful PPQs that led to licensure, and has supported the manufacture of 8 different commercial products.

His broad experience includes products that range from viral vectors used in cell and gene therapy, monoclonal antibodies, and enzymes to treat ultra rare diseases that are produced using continuous manufacturing technologies. Dr. Forestell was educated at the University of Guelph, earning a BSc in Biological Engineering and a Ph.D. in Chemical Engineering from the University of Calgary. He has co-authored 19 articles in peer-reviewed journals and is an inventor on two issued patents. | Learn More

Steven Chamow, Ph.D.
Principal Consultant

Steven Chamow is an experienced biotechnology executive and consultant, with more than 35 years of biopharmaceutical experience. As principal consultant, Dr. Chamow draws on his extensive technical and product development background to assist biotechnology companies in designing and developing CMC strategies for products in development, including transfer to and implementation by qualified CDMOs.

Prior to founding Chamow & Associates, Dr. Chamow served as senior vice president, CMC at Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics). Prior to Intradigm, Dr. Chamow was vice president, process sciences, at Genitope Corporation and at Abgenix, Inc. (acquired by Amgen), where he built the company’s process sciences department and co-led the design and construction of Abgenix’s award-winning mammalian-cell production facility in Fremont, CA. | Learn More

Elijah Tan
Senior Consultant

Elijah Tan is an accomplished regulatory affairs CMC consultant with over 25 years of experience in the pharmaceutical and biotechnology industries. His expertise is reinforced by dual US and EU RAC certifications, and he is recognized for his strategic vision, cross-functional leadership, and deep knowledge of global regulatory requirements for innovative biologics and advanced therapies.

Elijah held senior regulatory roles at Coherus BioSciences, Genentech, and Biogen. At Coherus, he was the Global Regulatory Leader responsible for the licensing of biosimilars, led critical health authority meetings and authored key submission documents. At Genentech, he served as Associate Regulatory Program Director, supporting both early and late phase biologics across multiple therapeutic areas, and led technical teams through complex global filings. Elijah started his consulting career in 2017 and has played a pivotal role in the successful approval of multiple Biologics License Applications and Marketing Authorization Applications (MAAs) across the US, EU, and other major markets. His recent projects include leading regulatory CMC strategies for products in late-stage development, supporting agency interactions, and mentoring regulatory professionals, with a focus on complex products such as oncolytic viruses, gene-edited therapies, and drug-device combinations.

Russ Lehrman, PhD
CMC Strategy / Drug Delivery / Biologics / Small Molecule Development / Executive Leadership

Russ Lehrman, Ph.D. is an accomplished biotechnology executive and consultant with over 35 years of experience in the biopharmaceutical industry. He specializes in product development and CMC strategy, supporting companies in designing and implementing robust development plans, including technology transfer and execution through qualified CDMOs. Dr. Lehrman is the Founder and CEO of BioSuperior Technology, Inc., a preclinical-stage company developing a proprietary synthetic lung surfactant for respiratory therapy and targeted drug delivery to the deep lung. He also served as a Senior Investigator at Nektar Therapeutics, where he advanced dry powder inhalation formulations for biologics, and held leadership roles in drug delivery R&D at InteKrin, Elan, NeXstar, and The Upjohn Company.

Dr. Lehrman earned a B.Sc. in Chemistry from McGill University and a Ph.D. in Pharmaceutical Chemistry from the University of Wisconsin–Madison, followed by postdoctoral research at the National Cancer Institute and Hoffmann-La Roche. He is an inventor on 12 patents and has contributed to the development of marketed therapeutics including Macugen, Exubera, and Tysabri. He has authored over 50 peer-reviewed publications including a book chapter on protein chemistry.

John Henstrand
CMC Downstream Process Development and Manufacture

John Henstrand is an expert in downstream processing, with over 25 years' biotherapeutic manufacturing experience. Dr. Henstrand has shepherded processes from the bench, through clinical, process performance qualification and commercial production. He has extensive experience in implementing post-marketing changes as part of continuous process improvement efforts.

He served as the downstream subject matter expert for six commercial processes. Over his long career at BioMarin, he directed the purification and analytical lab and the process engineer team that supported three onsite manufacturing facilities. His experience includes recovery and purification operations for AAV viral vectors, complex proteins from continuous and fed batch mammalian cell culture and fed batch microbial (bacterial and yeast) production systems. Additionally, Dr. Henstrand’s expertise includes clinical and commercial manufacturing experience with conjugated protein therapeutics.

Dr. Henstrand attended the University of California, Davis, earning a BS in Bacteriology. He received his PhD in Plant Physiology from Purdue University. His research experience includes a post-doctoral fellowship in Plant Biochemistry at the Swiss Federal Institute of Technology, Zurich. He has co-authored 11 articles in peer-reviewed journals and is an inventor on two issued patents.

Mir Ali
Senior Consultant

Mir Ali is a seasoned Quality Assurance and Compliance professional with over 25 years of experience in the biotechnology and pharmaceutical industries. With a strong foundation in manufacturing, testing, and regulatory compliance, he has spent nearly two decades in leadership roles overseeing supplier quality management, global audits, and post-approval regulatory filings. His expertise spans GLP, GPV, analytical chemistry, process validation, and quality system development.

Throughout his career, he has successfully led teams, ensured compliance with international regulatory standards, and facilitated technology transfers. Holding an MBA and professional certifications, Mir remains dedicated to excellence in quality assurance and compliance, making him a valuable leader in the industry.

Arnie Horwitz, Ph.D.
Senior Consultant

Arnie Horwitz, Ph.D. is a Senior Consultant for CMC at Alira Health. Arnie has more than 35 years of experience in the biopharmaceutical industry. His specialties include antibody and protein engineering and antibody humanization, expression of recombinant proteins in mammalian and microbial cells, optimization of mammalian expression systems, upstream process development, technology transfer, CDMO activity management, drafting of CMC documents and patent generation and evaluation.

As a consultant for more than 7 years, Arnie has worked with a number of companies to provide guidance in his areas of expertise.

Arnie holds a Ph.D. in Microbiology from the Pennsylvania State University.

Evan Greger
Technical Operations, CMC Upstream/Downstream Process Development and Manufacturing

Evan Greger is an experienced biotechnology executive and consultant, with more than 30 years of biopharmaceutical experience. As a senior CMC Consultant, Evan leverages his extensive technical background focused on the process/product development and commercialization of diverse biologics, with modalities including cell therapies, monoclonal antibodies, recombinant proteins, and vaccines.

Evan is currently a strategic advisor to the BOD of Gene Solutions. He joined Alira Health from Pionyr Immunotherapeutics, where he served as Chief Technical Officer and Senior Vice President of Technical Operations. Prior to this, Evan worked in executive roles for three industry leaders in CAR T autologous therapy: Cell Design Labs (acquired by Kite Pharma/Gilead Sciences), Juno Therapeutics (acquired by Celgene/BMS), and Novartis in Basel, Switzerland, where he contributed to the commercialization of the CAR T therapy Kymriah® and life cycle activities for Cosentyx®, Ilaris®, and Simulect®. Earlier in his career, Evan worked for nine years at Amgen, driving CMC activities for Enbrel®, Vectibix®, and two biosimilars (Amjevita® and Mivasi. At Aventis (acquired by Sanofi Pasteur), he managed the Merck alliance for the hexavalent vaccine Vaxelis® and performed legacy validation on vaccines. Evan has an M.Sc. from University of Washington and an M.B.A. from Seattle University.

Kelly Weitzel
Project Manager

Kelly has 10 years of experience in the biotech industry, focusing on analytical chemistry and project management. She works with AH consultants to plan and coordinate team activities for client projects, organize meetings, track action items and deliverables to ensure timeline and budget goals.

Peter Alexander, Ph.D.
Senior Consultant, CMC
Upstream Process Development/ DS Manufacturing

Peter Alexander, Ph.D., is a Senior Consultant for CMC at Alira Health. Peter has more than 35 years of experience in the biopharmaceutical industry. Peter supports clients by overseeing DS operations at CDMOs, including reviewing protocols, reports and manufacturing batch records. His specialties include microbial fermentation and mammalian cell culture process development and scale-up, purification process development, technology transfer, manufacturing sciences, cGMP manufacturing and biological and chemical safety programs. Peter holds a PhD in Microbiology from the University of Hawaii. | Learn More

Bill Perry, Ph.D.
Senior Consultant, CMC
Downstream Process Development/Conjugation/ DS Manufacturing

Bill Perry, Ph.D., is a Senior Consultant for CMC at Alira Health. Bill is a bioprocess engineering technical leader with 17 years of experience in industry. Bill supports clients by overseeing DS operations at CDMOs, including reviewing protocols, reports and manufacturing batch records. His experience includes products at various stages of development, from pre-clinical/clinical development and manufacturing, through process validation and commercialization. He has expertise in biologic products from mammalian cell culture and microbial fermentation. Moreover, he has skills in synthetic oligonucleotide and protein-payload conjugated products. He holds a PhD in Chemical Engineering from the Massachusetts Institute of Technology. | Learn More

Katie Black, Ph.D.
Consultant, CMC
Analytical Method Development and QC

Katie Black, Ph.D., is a Consultant for CMC at Alira Health. Katie Black is an experienced leader with 10 years industry experience and a multidisciplinary background spanning preclinical research through analytical development/CMC and clinical assay support. Katie’s support for clients includes overseeing the development, transfer, implementation and qualification of analytical methods at contract laboratories and CDMOs, including reviewing protocols, reports and SOPs and interpreting analytical data. Her tenure at BioMarin Pharmaceutical showcased her diverse skills in biomarker and product characterization assay development for protein therapeutics. Katie holds a BS in Chemical Engineering from Northeastern University, and a PhD in Bioengineering from UC Berkeley, with earlier industry experience at Albany International, Genzyme, and Draper Labs. | Learn More

Sanjeevani Ghone, Ph.D. MBA
CMC Operations Management Executive

Sanjeevani is a CMC Operations Management Executive, founder, and consultant of Sachemie Consultancy LLC, providing consultative support in CMC operations to biotech and pharmaceutical clients. In her most recent position, she was the Site Head and Senior Vice President of Chemistry Operations at Abzena, Bristol, PA. She has over 25 years of experience in discovering, developing, and manufacturing small and large molecules. Her expertise includes the development of complex small molecules (payloads, payload-linkers, polymers, peptides, carbohydrates, etc.), bioconjugates, and Antibody-drug conjugates. Sanjeevani led several cross-functional teams in operations to move advanced therapeutic molecules from discovery to IND. She co-authored several patents, publications, and review articles.

Sanjeevani served as Subject Matter Expert to biotechnology innovators and investors for open innovation and emerging business models. She achieved the strategic objectives through mergers and acquisitions to maintain industry leadership and was an advisor for due diligence, technology assessment, portfolio review, and post-acquisition integration.

Stephen Nava
Quality Assurance/Regulatory Affairs

Steve is a Quality Assurance/Regulatory Affairs Professional with 30+ years of experience in cGMP compliance and quality systems. Steve is an ISO9000-trained auditor with a solid foundation in worldwide quality and regulatory requirements and a thorough knowledge of cGMP guidelines. His experience includes auditing vendors for phase appropriate clinical development through mock-PAI readiness. Completed 100+ audits across the supply chain including intermediates/key starting materials, biologically active substance, drug substance, parenteral, solid oral dosage, topical and medical device manufacturing operations within the United States, Europe, China, Japan, Southeast Asia, and India. Experience includes both small and large molecules (i.e., monoclonal antibodies (mAb), Antibody-drug conjugates (ADC), Biosimilars, and Bispecific antibodies (bsAbs)). Developed/Managed quality assurance/regulatory affairs, compliance, and medical writing departments. Implemented phase-appropriate quality systems, managed supply chains, provided CMC regulatory submission strategy for both US and ex-US dossiers, authored modules 2 and 3 for INDs, IMPDs, NDAs and MAAs in eCTD format and provided oversight for project technology transfer of manufacturing/analytical operations.

Chris Garten
Quality Assurance, Quality Control, Supply Chain

Chris Garten is an executive Quality professional with over 30 years of global Quality Assurance, Quality Control, Supply Chain and organizational leadership in pharmaceutical, biologics, and cell & gene development. With an extensive background in GMP, GCP, GLP, and GVP, Chris has proven success in navigating complex regulatory environments, including 21 CFR 210/211/1271, 21 Part 11, GAMP5, GCP ICH Guidance, and corresponding EU Tissue and Cell Directives. Chriss's experience spans R&D translational, clinical, and commercial quality for small molecules, large molecules, and advanced therapies. Chris has 15 years of senior leadership at emerging companies such Synthekine, BlueSphere Bio and PACT Pharmaceutical developing and implementing phase appropriate quality strategies and systems supporting global Phase 1-3 cell and gene therapy clinical studies. Prior to his transition into emerging technologies, Chris supported organizations such as GlaxoSmithKline, Schering Plough Research Institute, Forest Laboratories, Inc., Aventis Pharmaceutical, and Johnson & Johnson with a focus on global quality operations. Throughout his career, Chris has been a key quality liaison for health authorities including FDA, EMA, MHRA, and Asian health authorities.

Nats Rajagopalan
Biologics Formulation Development and Drug Delivery

Nats Rajagopalan is an experienced biologics drug product development consultant with more than 40 years of experience in the pharmaceutical industry in both technical and management roles. Over his career in the industry, Dr. Rajagopalan has been involved in the development of biotechnology drug products, drug delivery systems and gene therapy systems for the delivery of nucleic acids. He has a broad background and expertise in the preformulation and formulation development of biologics including peptides, fusion proteins and monoclonal antibodies, development of combination drug products in prefilled syringe systems and in technology transfer and commercial manufacturing of solution and lyophilized drug products.

Dr. Rajagopalan has worked extensively in the area of high concentration biologics for delivery of biotherapeutics by the subcutaneous route. He has been involved in the clinical and commercial development of high concentration formulation of monoclonal antibodies and has a strong understanding of PK/ADME aspects related to subcutaneous delivery. He has broad experience in conducting due diligence evaluations for assessment of new technologies and for in licensing of early and late phase assets.

Lars Schuller

Lars brings over 20 years of Manufacturing and Quality Assurance experience in Pharma, Biotech and Medical Devices. He has extensive experience in the establishment and remediation of Quality Systems, Change Control (process, material, and facility) as well as process design and continuous improvement. He brings a practical approach to managing and solving issues based on experience and industry best practices. Lars holds a BS in Biochemistry with a second major in Chinese from Trinity University in San Antonio and an MBA from University of California, Los Angeles.

Melisa Carpio

Melisa Carpio has over 20 years of experience in the biotechnology industry working at Genitope, MedImmune, Takeda, Sartorius, and Repligen. The core of her expertise is in cell line development and upstream bioprocessing. She has a proven track record of supporting the advancement of molecules from discovery to the clinic and has worked with over 100 clients using various cell lines (CHO, 293, insect, yeast, bacteria), molecule types (mAb, ADC, cell and gene therapy), expression systems, and bioreactor platforms.

As a Senior Consultant, Melisa’s project involvement includes global CDMO sourcing and oversight, technical support for program advancement, due diligence, technical writing for regulatory submissions, technology benchmarking, and market assessments.

Melisa has a B.S. and M.S. in Chemical Engineering from the University of California, Berkeley and Management of Technology Certification from the Haas School of Business.

Peter Hocknell, PhD
CMC Analytical Development and Quality Control

Peter Hocknell has over 22 years of experience in the field of analytical development for a wide range of biologic modalities. These include enzyme replacement therapies, therapeutics viruses, monoclonal antibodies, and fusion proteins with multiple specificities. As senior consultant, Dr Hocknell uses his experience solving assay development challenges to assist biotechnology and biopharma companies in designing and validating analytical strategies for products in their development pipeline. This often includes method transfer to, and qualification / validation by, qualified CROs.

Originally trained as a viral immunologist, Dr Hocknell gained an appreciation for the importance of high-quality and robust analytical assays to help answer perplexing scientific questions early in his career. These include cell-based potency assays, which can be particularly challenging to develop but offer critical insights into a therapeutic agent’s mechanism of action in the patient. In addition, Dr Hocknell has extensive experience preparing INDs/IMPDs for Regulatory submissions to Health Authorities in the US, Europe, and Asia.

Greg Davies
Formulation Development, Manufacturing, New Product Introduction

Greg Davies is an expert in formulation development, manufacturing, and new product introduction with over 30 years industry experience. He has held senior positions at SmithKline Beecham, GSK, and Impel Pharmaceuticals, a small Seattle based biotech. These have included positions in manufacturing technical support, new product development, new product introduction and supply chain, contributing to over fifty new products. His areas of expertise include formulation development, product remediation, process development and technology transfer, manufacturing sourcing evaluation and selection, and establishing commercial manufacturing and supply chain for new products.

Greg has managed large and small global teams in product development, technical support, and vendor management of CDMOs developing and manufacturing pharmaceutical products. Over his career, he has led development of conventional solid, liquid, and semi-solid dosage forms, as well as novel formulations and medical devices to improve drug delivery. He has also managed a global team responsible for the selection of the commercial site of manufacture, through technology transfer and establishing the supply chain for new product multi-market launches. Greg holds a B.Sc. in Chemistry from Hull University, UK.